NA 391.98Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10887587041070), received between Sep 10, 2019 and Aug 29, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2022Break; Break

  IT WAS REPORTED THAT DURING ROUTINE INSPECTION, THE PLATE CUTTER AND TIP FOR PLATE HOLDER BOTH WERE FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) PLATE CUTTER FOR 1.0MM, 1.3MM, 1.5MM, 2.0MM PLATES. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15316003 ↗
• MalfunctionOct 16, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2020, TWO (2) MESH CUTTER HAD A BROKEN BLADE ON IT. NO PARTS LEFT IN THE PATIENT. PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO DELAY TO THE SURGERY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) PLATE CUTTER FOR 1.0MM, 1.3MM, 1.5MM, 2.0MM PLATES. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10691443 ↗
• MalfunctionOct 16, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2020, TWO (2) MESH CUTTER HAD A BROKEN BLADE ON IT. NO PARTS LEFT IN THE PATIENT. PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO DELAY TO THE SURGERY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) PLATE CUTTER FOR 1.0 MM, 1.3 MM, 1.5 MM, 2.0 MM PLATES. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10691440 ↗
• MalfunctionOct 15, 2020Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON SEPTEMBER 1, 2020, AN INVENTORY CHECK OCCURRED AND MULTIPLE DEVICES INCLUDING A MESH CUTTER, RIGHT ANGLE BENDER, PLATE CUTTER, 90 DEGREE SCREWDRIVER T-HANDLE, HANDLE FOR 90° SCREWDRIVER, SHAFT FOR 90° SCREWDRIVER, AND MATRIX RIB SCREWDRIVER BLADE SELF-RETAINING F/90° SCREWDRIVER WERE FOUND WITH MALFUNCTIONS. WHEN TESTED, THE DEVICES WOULD NOT WORK PROPERLY. THEY WOULD NOT TURN, HOLD SCREWS, AND SOME WERE STRIPPED. SOME INSTRUMENTS WERE BENT OR DULL. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) PLATE CUTTER FOR 1.0 MM, 1.3 MM, 1.5 MM, 2.0 MM PLATES. THIS IS REPORT 8 OF 8 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10684490 ↗
• MalfunctionSep 10, 2019Break; Break

  IT WAS REPORTED ON (B)(6) 2019, DURING MAINTENANCE INSPECTION BY THE SALES CONSULTANT. ONE OF THE JAWS OF THE PLATE CUTTER WAS NOTICED TO HAVE CHIPPED. THERE WAS PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) PLATE CUTTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8982768 ↗